Study of IMMU-132 in HR+/HER2- MBC (TROPICS-02)

Purpose

This is an open-label, randomized, multicenter Phase 3 study to compare the efficacy and
safety of Sacituzumab Govitecan versus TPC in subjects with metastatic or locally recurrent
inoperable HR+/HER2- MBC, after failure of at least 2, and no more than 4, prior chemotherapy
regimens for metastatic disease.

Females must not be lactating or pregnant at Screening or Baseline (as documented by a
negative beta human chorionic gonadotropin [ß-hCG]

Exclusion Criteria

Previous treatment with Topoisomerase 1 Inhibitors as a free form or as other
formulations

History of significant cardiovascular disease or clinically significant ECG
abnormality

Patients with Gilbert's disease.

Active infection requiring intravenous antibiotic use

Patients with a history of an anaphylactic reaction to irinotecan.

Other concurrent medical or psychiatric conditions that, in the Investigator's
opinion, may be likely to confound study interpretation or prevent completion of study
procedures and follow-up examinations.

Locally advanced MBC (stage IIIc) in subjects who are candidates for curative intent
therapy at the time of study enrollment

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health).
The listing of studies provided is not certain to be all studies for which you might be eligible.
Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

This study (NCT03901339) was last processed and updated on 6/2/2020 by ClinicalTrials.gov.